This invention relates to maintaining a chain of custody for object handling, and more particularly, to a chain of custody form or associated label including a radio frequency identification chip allowing electronic chain of custody form processing.
Important decisions are often made based on laboratory analyses. For example, a physician will often decide on a diagnosis or a treatment based on lab results. In other contexts, an employer might make a hiring or a firing decision based on the results of a drug test, or a court or jury might decide a legal case based on lab results of a DNA test, blood alcohol test or the like.
Important questions that may arise in these (and other) contexts is whether the laboratory tested the correct sample, and whether the sample was tampered with before it was tested. While the possibility of intentional tampering might seem unlikely, criminal defendants often allege that law enforcement officials and/or laboratory personnel have tampered with incriminating evidence in order to xe2x80x9cframexe2x80x9d the defendant. More commonly, there is always the possibility of mixing up samples or test results between different people. Imagine a situation in which samples from two different patients get mixed upxe2x80x94resulting in both patients being given incorrect diagnoses and treatments. It is very important that the laboratory and/or hospital or office personnel responsible should take care to prevent mix-ups from occurring.
The most effective way to avoid such problems is to establish a strict chain of custody for each laboratory sample. Generally, a chain of custody process tracks or audits the sample as it passes through each step. To establish and evidence chain of custody, laboratories commonly use specialized chain of custody forms requiring each and every custodian of a particular sample to certify certain information. For example, the person who collects the sample typically certifies his or her identity and the time and date on which the sample was collected. The courier, common carrier or other entity transporting the sample from the collector to the laboratory may provide, on the same or different form, a certification establishing courier identity, how long the courier had the sample, etc. Seals applied to the sample or its container can establish that no one has tampered with the sample in transit. The laboratory receiving the sample may complete an additional portion of the chain of custody form to evidence when the sample was received and by whom, when the test was performed and by whomxe2x80x94all of which information can be used to establish a very strict evidentiary basis and assurance that the sample has not been mixed up with another sample, has not become stale or spoiled, and has not be tampered with. Commonly-assigned U.S. Pat. No. 5,976,014 to Petrick et al. entitled xe2x80x9cIntegrity Seal Form/Label Combinationxe2x80x9d discloses a particularly advantageous business form that can be used to provide evidence of chain of custody and absence of sample tampering.
While existing chain of custody forms and associated procedures are often successful in establishing a rigorous chain of custody that virtually eliminates the possibility of sample mix-ups and tampering, a problem still remains that such existing forms and associated procedures are typically time-consuming to follow and complete. Commonly, each and every custodian of the sample must take the time to complete all of the information required on the chain of custody form. There is often no backup source for missing informationxe2x80x94requiring a new sample to be collected and re-tested. In life-threatening or other time-critical situations, the time required for re-testing may mean the difference between a favorable or an unfavorable outcome. In legal contexts, it may be impossible to go back and re-testxe2x80x94so that even a single missing piece of information on the chain of custody form might be outcome-determinative. In addition, chain of custody forms and procedures (like all human endeavors) are subject to human error.
Some ability to perform automatic backup checking and/or to automate some of the chain of custody processes would be highly desirable. While computers and other automation equipment have been used in the past in connection with chain of custody processes, many such arrangements require extensive data entry and/or optical scanning technology to enter data into any of several computer systems used to track the sample and the form. Accordingly, further improvements are possible and desirable.
The present invention overcomes these problems by providing a new chain of custody form and/or associated label that includes a radio frequency identification chip. The radio frequency identification (RFID) chip allows pertinent data to be monitored and filed electronicallyxe2x80x94minimizing the need for a multi-part form and reducing consumable costs to the customer.
In accordance with one aspect of the invention, data is tracked automatically using the RFID chip. The chip or processes associated therewith can prompt a data collector to enter the data correctly. An unbroken chain of custody can be automatically maintained accurately through automated means. The RFID chip allows data to be shared electronically with various parties (e.g., employer, collection site, medical review officer, and third party administrator) without need to rekey the information. Automatic entry of the data may occur upon the specimen entering the laboratory. Since the RFID chip allows for complete tracking of the specimen, loss of samples in transit or at a lab is minimized and positive identification becomes more reliable.